Actively Recruiting
A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-13
46
Participants Needed
8
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to find out whether adding belumosudil to a usual approach for reducing the risk of graft-versus-host disease (GVHD) may be an effective GVHD prevention approach for people with blood cancer who have a stem cell transplant. The investigators will also look at the safety of the study approach.
CONDITIONS
Official Title
A Study of Belumosudil in People at Risk of Developing Graft-Versus-Host Disease After a Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older at time of consent
- Diagnosed with hematologic malignancy in remission and treated with reduced intensity or non-myeloablative conditioning plus calcineurin inhibitor-based GVHD prophylaxis with abatacept or post-transplant cyclophosphamide
- Receiving a 7-8/8 matched related or unrelated or haploidentical donor stem cell transplant
- Peripheral blood stem cell graft recipients
- Within 120 days after allogeneic hematopoietic cell transplant at time of consent
- Post-transplant within 3 weeks before starting belumosudil treatment: in morphologic remission with less than 5% blasts and no extramedullary disease
- Achieved engraftment defined by ANC ≥ 500/µL and platelets ≥ 20000/µL on 3 measurements at least one day apart without platelet transfusion within 7 days before first measurement
- Between 80 and 20 days post-transplant infusion
- Karnofsky performance score ≥ 70%
- Liver enzymes ALT and AST ≤ 3 times upper limit of normal
- Total bilirubin ≤ 1.5 times upper limit of normal unless benign
- Glomerular filtration rate ≥ 30 mL/min/1.73 m2
- Female subjects of childbearing potential ≤ 50 years must have negative pregnancy test and agree to use two forms of contraception during and for 3 months after treatment
- Male subjects with partners of childbearing potential must agree to use two forms of contraception and avoid sperm donation during and for 3 months after treatment
You will not qualify if you...
- Recipients of CD34+ selected or engineered stem cell grafts
- Treatment with in vivo T cell depletion such as anti-thymocyte globulin
- Uncontrolled cardiovascular conditions including arrhythmias, symptomatic heart failure, unstable angina, or recent myocardial infarction within 6 months
- Pulmonary dysfunction with corrected DLCO less than 50%
- Post-transplant uncontrolled infections including active hepatitis B or C without definitive therapy and no progression within 7 days before treatment
- Use of investigational agents within 14 days before transplant or anytime after
- Active acute or chronic GVHD requiring systemic therapy (topical or local therapies allowed)
- Active corticosteroid treatment at dose ≥ 0.25 mg/kg/day for non-GVHD reasons
- Uncontrolled psychiatric conditions including psychosis, suicidal ideation, or recent hospitalization within one year
- Pregnant or breastfeeding female patients
- Prior treatment with belumosudil
- Known allergy or sensitivity to belumosudil or other ROCK2 inhibitors
AI-Screening
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Trial Site Locations
Total: 8 locations
1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited protocol activity)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
New York University (Data Collection Only)
New York, New York, United States, 10010
Actively Recruiting
7
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
8
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, United States, 11553
Actively Recruiting
Research Team
D
Doris Ponce, MD
CONTACT
G
Gajan Raju, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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